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Showing 64021–64040 of 68218 results

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American Medical Systems: AMS 700 CX Preconnected penile Prosthesis with InhibiZone...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

GE OEC Medical Systems, Inc: OEC 9800 Fluoroscopic X-ray System, Model Number A349855,...

During routine service, a cover may have been installed without the required proper lead shielding.

FDAFeb 9, 2007Nationwide• GE OEC Medical Systems, Inc

HoMedics, Inc.: HoMedics Thera P Model King size Moist/Dry Heating Pad wi...

Fire/Burn Risk

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

FDAFeb 9, 2007Nationwide• HoMedics, Inc.

HoMedics, Inc.: HoMedics Thera P Standard size Dry Heating Pad; Model No....

Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.

FDAFeb 9, 2007Nationwide• HoMedics, Inc.

American Medical Systems: AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis wit...

The carton labeling does not match the product packaged inside.

FDAFeb 9, 2007Nationwide• American Medical Systems

Bausch & Lomb Inc: Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. ...

Laceration Risk

The cutter probe tip breaks during use.

FDAFeb 9, 2007CA, FL, MO +2 more• Bausch & Lomb Inc

Ekos Corp: EKOS EndoWave Infusion System and EKOS Lysus Infusion Sys...

Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient.

FDAFeb 9, 2007Nationwide• Ekos Corp

Medtronic Cardiac Surgery Technologies: Medtronic U-CLIP Anastomotic Device Removal Tool, model R...

Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.

FDAFeb 8, 2007Nationwide• Medtronic Cardiac Surgery Technologies

Boston Scientific Target: Matrix2 Detachable Coils, vascular embolization device....

The product may be missing the temperature indicator label on the inner pouch.

FDAFeb 7, 2007Nationwide• Boston Scientific Target

Boston Scientific Corporation: Boston Scientific SpyGlass Light Cable Reference Number: ...

Light Degradation in transmission-A film may deposit on the front face and limit transmission of light

FDAFeb 7, 2007Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific SpyGlass Camera Ref Number: 4610 UPN M0...

A teal "bloom"/ glare on the subject image during high light conditions.

FDAFeb 7, 2007Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific SpyGlass Visualization Probe Reference ...

SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

FDAFeb 7, 2007Nationwide• Boston Scientific Corporation

Kensey Nash Corp: ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150...

Face seal may wear excessively and cause particulate matter.

FDAFeb 7, 2007Nationwide• Kensey Nash Corp

Boston Scientific Corporation: Boston Scientific SpyGlass Ocular Reference Number: 4604 ...

SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

FDAFeb 7, 2007Nationwide• Boston Scientific Corporation

Steris Corporation: Cmax Surgical Table, Model No. 2182625, Manufactured by S...

A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.

FDAFeb 6, 2007Nationwide• Steris Corporation

General Electric Med Systems LLC: GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging...

Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely.

FDAFeb 5, 2007AL, AK, AZ +38 more• General Electric Med Systems LLC

General Electric Med Systems LLC: GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic ...

Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller that may impact patient or staff safely.

FDAFeb 5, 2007AL, AK, AZ +38 more• General Electric Med Systems LLC

Sonosite, Inc.: MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasoun...

Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

FDAFeb 5, 2007OH, TN• Sonosite, Inc.

General Electric Med Systems LLC: GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic I...

Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller that may impact patient or staff safely.

FDAFeb 5, 2007AL, AK, AZ +38 more• General Electric Med Systems LLC

Medtronic Inc. Cardiac Rhythm Managment: Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive...

Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

FDAFeb 5, 2007AL, AZ, AR +19 more• Medtronic Inc. Cardiac Rhythm Managment

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